FDA 510(k) Application Details - K250559

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K250559
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	GM Dos Reis Industria e Comercio Avenida Pierre Simon de LaPlace, 600 Campinas 13069320 BR Other 510(k) Applications for this Company
Contact	Guilherme Esteves Pontes Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2025
Decision Date	06/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review